The present invention relates in general to a tracheostomy tube dressing for covering the wound about a patient's neck such that the wound area can be covered while it is also allowed to heal.
Although opaque dressings have long been in use, their designs suffer from several drawbacks. First, the patient or person treating the patient has no idea how well the wound is healing until the dressing is entirely removed. Second, removal of the dressing increases the danger that the scab or skin covering the wound will be removed along with the dressing. Another drawback is that many dressings fail to adequately aerate the wound. In such instances, the healing of the wound is much slower. Another drawback of many conventional dressings is that part of the wound area is contacted by an adhesive portion of the dressing. Thus, when the dressing is removed, the tacky surface of the dressing will possibly harm the partially healed area.
These drawbacks are compounded in tracheostomy tube dressings where the dressing must serve the dual function of protecting the wound and holding the tracheostomy tube in place. Such a dressing must avoid the above drawbacks common to all dressings and still present a sufficiently rigid clamp for the tracheostomy tube.
To date, those transparent dressings and tracheostomy dressings that have been devised fail to avoid these drawbacks.
For example, the 3-M Corporation markets a transparent dressing under the trademarked name "TEGADERM" and the Johnson & Johnson Company sells a transparent dressing under the name "BIOCLUSIVE". Both dressings consist of a transparent air and vapor permeable film that have the surface of one side entirely coated with an adhesive. The dressings are supplied with releasable paper frames adhered to the non-adhesive side of each sheet. A paper frame is used in each dressing to maintain the integrity of the dressing's shape before it is applied to the patient's skin. Once applied, the frame is removed.
Although the "TEGADERM" and "BIOCLUSIVE" dressings are relatively simple in their construction, their adhesive surfaces may harm healing tissue when the dressings are removed. Another problem is that water or contaminants may seep into the wound site from the sides of the dressing due to the lack of a sealing frame.
The "TEGADERM" product also includes a design for use as a tracheostomy dressing. In this application, a slit is cut to extend from an edge of the dressing to the center. A center hole having the same diameter as a tracheostomy tube is then cut so that the slit contacts one side of the hole. The combination of the slit and center hole allow the bandage to be spread apart along the slit in order that a tracheostomy tube and cuff can easily slide into the center hole. When the slit is closed, the center hole surrounds the tube below the cuff and collar substantially enclosing the tube. However, the "TEGADERM" tracheostomy dressing does not contain a structure for securing the tracheostomy tube to the patient's neck. Instead, the tube is independently secured to a patient's neck by means of cloth ties which completely encircle the patient's neck. Thus, the cloth ties do not adequately hold the tube to the bandage. Movement of the ties or of the dressing will cause stress on the tube. The cloth ties also create a substantial risk of infection to patients having undergone recent surgery to the head and/or neck. Moreover, if the ties are made too tight, they can potentially choke the patient. The cloth ties are also susceptible to bacteria, creating a greater risk of infection around the puncture area for the tube. The cloth ties also create a substantial risk of infection to patients having undergone recent surgery to the head or neck. Finally, the cloth ties are inconvenient, requiring the treating nurse or physician to physically untie or retie a knot each time they wish to remove or adjust the tube.
Another transparent dressing is sold under the registered trademark "VENI-GARD" by the Conmed Corporation. "VENI-GARD" is a disposable dressing for holding an IV needle or catheter in a patient's vein. The "VENI-GARD" provides a sterile barrier over the puncture site and incorporates a transparent semi-permeable membrane material as the covering over the site. The purpose of the transparent membrane is to allow unobstructed visualization of the puncture locus while at the same time enabling the evaporation of any moisture that collects around the puncture site. However, the construction of the VENI-GARD dressing is complex. Further, the membrane is coated with an adhesive that renders the VENI-GARD unsuitable for use in covering a wound because the adhesive surface may harm the healing tissue when the dressing is removed.
Another example of a transparent dressing is shown in the Gordon patent, U.S. Pat. No. 4,341,208. The Gordon dressing has a transparent window and a flexible frame for adhering the window to the patient's skin. Thus, unlike "VENI-GARD," the Gordon dressing does not contact the adhesive layer to the wound. However, the material used with the window does not allow for the passage of air or moisture from the patient's skin to the exterior surface of the dressing. Moreover, the construction of the Gordon dressing requires a multiple layered window which employs an applicator layer adjacent to the transparent layer. The applicator spaces the window from the skin by the thickness of the frame which is not as sterile as an adjacent film because the spaced film traps air or other substances adjacent to the skin.
Another transparent dressing is illustrated by the Klein patent, U.S. Pat. No. 2,273,873. The Klein dressing involves a transparent adhesive sheet adapted to be used as a dressing for a wound. The wound is not sealed from outside contaminants since air passages are provided along portions of the frame of the dressing. In addition, the transparent material used in the Klein dressing is neither air nor vapor permeable, and the sheet does not contact the skin.
The Linsky et al. patent, U.S. Pat. No. 4,181,127, illustrates a non-adherent wound dressing employing an absorbent pad border that removes moisture from the area around the wound. A transparent film covers the wound and has its edges overlapped by an adhesive frame. However, the film is placed on top of the frame rather than below it, the materials of the frame are primarily webbing, and the film is an imperforate material that does not offer the advantages of a transparent air/vapor permeable barrier.
The Merriam et al. patent, U.S. Pat. No. 2,949,443, illustrates a water vapor permeable dressing applied directly to a surgical wound. The material of the dressing is primarily transparent and water and vapor permeable. However, the material is either applied to the skin through the use of an adhesive layer formed along the outer edge of the dressing, or through the application of an alcohol solvent applied to the skin directly. Such a construction does not adhere strongly to the patient's skin and may easily come loose from the wound area.
The Faasse, Jr. patent, U.S. Pat. No. 4,744,355, discloses a hinged releasable wound dressing in which a thin flexible polymeric film having an adhesive layer coated on one side of the dressing is applied directly to the site of the wound. The Faasse, Jr. dressing has the drawback of directly contacting the wound with adhesive which could cause the healing layer of skin to be pulled up when the dressing is removed.
Finally, the Dellas dressing illustrated in U.S. Pat. No. 4,485,809 provides for a transparent moisture vapor permeable film dressing. As in Faasse, Jr., the Dellas film also employs an adhesive in order to directly contact the dressing to the patient's skin. Therefore, the construction of the Dellas dressing can cause tearing of the partially healed wound when the dressing is removed from the patient's skin.